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A randomized controlled trial of telephone-delivered cognitive behavioral therapy, modafinil, and combination therapy of both interventions for fatigue in multiple sclerosis
Investigator (PI): Braley, Tiffany; Kratz, Anna
Performing Organization (PO): (Current): University of Michigan, Michigan Medicine, Department of Neurology / (734) 936-9010
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2018
Final Year: 2022
Record Source/Award ID: PCORI/MS-1610-36980
Funding: Total Award Amount: $3,156,832
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Many individuals with multiple sclerosis (MS) suffer from fatigue, which is often their most disabling symptom. Treatments for MS fatigue are limited, so it is important to maximize the effectiveness of available therapies, which should include tailoring the treatment to the individual. Unfortunately, health care providers have little information to help guide them when they are creating a fatigue treatment program for a patient with MS and fatigue. For example, providers have little information to help them decide whether a single therapy, such as a medication or behavioral therapy, will be enough for a given patient, or whether therapies should be combined to provide the best results. This clinical trial, which will be guided by feedback from MS patients, MS providers, community organizations, and payers, will compare the effectiveness of a commonly used behavioral treatment strategy (cognitive behavioral therapy), a commonly used medication (modafinil), and a combination of both therapies for fatigue in a large, representative group of patients with MS. Fatigue will be measured with a combination of patient centered survey measures as well as measures of physical activity and fatigue, which will be collected with a wrist-worn device as study participants go about their day. These measures will open a window into the day-to-day experiences of patients with MS, before and after treatment. The effects of other conditions and problems that are common in MS (depression, sleep disturbances, and disability), on response to each of the different treatments will also be assessed, which will be particularly helpful in terms of giving providers more information on how to tailor fatigue intervention plans to patients' individual circumstances and needs. Other factors related to the patient experience with these different treatments, such as how well people in each treatment condition followed the treatment program ("treatment adherence") and whether patients experienced any negative side effects. Results of this study will help patients, providers, and policy makers determine which patients with fatigue respond best to cognitive behavioral therapy or modafinil, and which MS patients may benefit most from a combination of these treatments.
Abstract Archived: PCORI has identified multiple sclerosis (MS) as an important research topic. Patients, clinicians, and others want to learn how different treatment strategies, aimed at changing specific symptoms or the overall course of MS, affect patients' symptoms and quality of life. To address this issue, PCORI launched a funding initiative in 2015 on Treatment of Multiple Sclerosis. This research project is one of the studies PCORI awarded as part this program. This research project is in progress. PCORI will post the research findings on the PCORI website within 90 days after the results are final. What is the research about? Multiple sclerosis, or MS, is a health problem that causes the body's immune system to attack the nerve cells in the brain and spinal cord, causing nerve damage. Fatigue is one of the most disabling symptoms people with MS have. There are few treatment options for fatigue, and doctors and patients have little information to guide the use of current treatments. One way to treat fatigue in patients with MS is with medicine. Another option is cognitive behavioral therapy, or CBT. CBT helps people develop new behaviors and ways of thinking that can lessen the intensity and impact of fatigue. In this study, the research team is comparing three ways of treating fatigue in patients with MS. The first is CBT. Modafinil, a medicine for fatigue, is the second way. The third way is a combination of these two therapies. The team is comparing how much each method lessens fatigue in MS patients. The team is also looking to see if certain patients respond better to one treatment over the others. Who can this research help? Results of this study may help patients with MS and their doctors decide whether to treat fatigue with CBT, modafinil, or both. What is the research team doing? The research team is recruiting patients, in southeastern Michigan and Seattle, Washington, who have problems with fatigue from MS. The team is assigning patients to one of three treatment groups by chance: CBT by phone with a therapist, modafinil, or a combination of both. The CBT treatment includes eight weekly telephone calls to help patients manage fatigue, followed by two check-in calls from a therapist the following month. The CBT addresses issues such as setting goals, improving sleep, and conserving energy. On the follow-up calls, patients make plans for managing fatigue in the future. At the start of the study, over the 12-week treatment period, and 12 weeks after treatment ends, the research team is asking patients about their fatigue, other MS symptoms, sleep, social functioning, and quality of life. Study participants wear a sensor around their wrists to track their physical activity. Across the three treatment groups, the team is comparing patients' levels of fatigue, how well they follow their treatment plan, and any side effects. The team is also comparing how well the treatments work for patients with MS who have other conditions, such as depression, sleep problems, or a disability. Patients with MS, their providers, payers, and national and regional MS organizations are helping to design the study and recruit participants. Research methods. Design: The study design is a randomized controlled trial. Population. The study population is adults ages 18 years and older with MS and chronic, problematic fatigue that interfered with daily activities for e3 months and an average Fatigue Severity Score (FSS) score of e4. Interventions/comparators are cognitive behavioral therapy, modafinil, and cognitive behavioral therapy plus modafinil. Outcomes: Outcomes are (1) primary: fatigue impact and (2) secondary: fatigue severity and fatigability. The timeframe is 12-week follow-up for study outcome.

MeSH Terms:
  • Benzhydryl Compounds /*pharmacology
  • Cognitive Behavioral Therapy /*methods
  • Combined Modality Therapy
  • Comparative Effectiveness Research
  • Exercise
  • Fatigue
  • Health Policy
  • Humans
  • Multiple Sclerosis /*drug therapy
  • /*psychology
  • Outcome Assessment, Health Care
  • Patient-Centered Care /organization & administration
  • Randomized Controlled Trials as Topic
  • Surveys and Questionnaires
  • Telemedicine /*methods
  • Wakefulness-Promoting Agents /*pharmacology
Country: United States
State: Michigan
Zip Code: 48109
UI: 20181647
CTgovId: NCT03621761
Project Status: Ongoing
Record History: ('2018: Project initial year changed to 2018 and final year extended to 2022.',) ('2020: Included Lay Abstract in Abstract Archived 1 field. Alternate Title: Comparing treatments for fatigue in patients with multiple sclerosis',)